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Abstract:

An apparatus for displaying and recording medical images and producing by
sketching or drawing line segments creating an electronic virtual road
map of a patient's anatomy for use by a physician during an intra-body
medical procedure. The apparatus includes among its essential elements,
an interventional device providing real time images of body structure of
the patient; a medical image acquisition system computer adapted for
acquisition of a plurality of medical imaging video signals wherein
signals are acquired from a transmitting medical device in the medical
device's native resolution having a central processing unit, a display,
at least one input device, a storage device, an output device wherein the
medical image is displayed on the display; and an image generating
device, wherein physician uses the input device to sketch or draw line
segments creating virtual road map of patient's anatomy over the medical
image. The drawing features can also be used as a teaching tool,
directing physicians as to what the plan for the procedure is. It can
also be used to document the planned procedure.
A method of displaying and recording a medical image during an intra-body
medical procedure, providing a medical image to a medical image
acquisition system acquiring a plurality of medical imaging video signals
wherein signals are acquired from a transmitting medical device in the
medical device's native resolution having a central processing unit, a
display, at least one input device, a storage device, an output device
wherein the medical image is transmitting to a display, displaying the
medical image on the display, viewing the medical image, the operator
positioning the input device wherein a line segment appearing on the
display, the operator, tracing segments using the input device, the
segments appearing on the display over and along with the medical image
creating curve segments coincident to the medical image.

Claims:

1. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure, comprising;an interventional device
providing real time images of body structure of the patient;a medical
image acquisition system computer adapted for acquisition of a plurality
of medical imaging video signals wherein signals are acquired from a
transmitting medical device in the medical device's native resolution
having a central processing unit, a display, at least one input device, a
storage device, an output device wherein the medical image is displayed
on the display; andan image generating device for generating for a
virtual road map, wherein the virtual road map comprises a two
dimensional image illustrations representing anatomy structure as imputed
by an operator.

2. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure as in claim 1 wherein the illustration
represents operator's input annotations.

3. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure as in claim 1 where in the illustration
represents vascular structure.

4. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure as in claim 1 wherein the medical images
are pre-recorded images.

5. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure as in claim 1 wherein the virtual road
map is sketched line segments.

6. An apparatus for displaying and recording medical images and producing
a virtual road map of a patient's anatomy for use by a physician during
an intra-body medical procedure as in claim 5 wherein the virtual road
map is sketched line segments chosen from a viable pallet of colors and
line weights.

7. A method of displaying and recording a medical image during an
intra-body medical procedure, comprising;providing a medical image to a
medical image acquisition system acquiring a plurality of medical imaging
video signals wherein signals are acquired from a transmitting medical
device in the medical device's native resolution having a central
processing unit, a display, at least one input device, a storage device,
an output device wherein the medical image is transmitting to a
display;displaying the medical image on the display, viewing the medical
image, the operator positioning the input device wherein a line segment
appearing on the display, the operator, tracing segments using the input
device, the segments appearing on the display over and along with the
medical image creating curve segments coincident to the medical image.

Description:

FIELD

[0001]The invention relates generally to a medical apparatus and method of
using the same for generating a virtual road map guide of a patient's
anatomy for use by a medical professional. The invention acquires medical
images and through an input device the operator electronically sketches,
annotates and stores a road map image overlaid on a captured medical
image. Wherein creating a virtual road map, drawing or tracing of
patient's anatomy and adding any additional information.

BACKGROUND

[0002]Many medical procedures involve inserting an interventional device
or typically a catheter into a patient for a variety of purposes. One
such procedure is commonly known as cardiac catheterization used to
obtain an angiogram. As part of this procedure a radiopaque dye or
contrast agent is injected into the bloodstream and a radiogram is taken
(better known as x-ray). An interventional device is any device that is
introduced onto or into the human body. Normally the physician will
insert the catheter into an artery in the human body and guide that
catheter through the arterial system to the desired location. In order to
position the catheter and monitor its location within the body of the
patient, one or more x-ray type images may be taken prior to injecting
dye for the angiogram. Angiography or arteriography is a medical imaging
technique used to visualize the inside, or lumen, of blood vessels and
organs of the body, with particular interest in the arteries, veins,
vasculature and the heart chambers. The interventional device or catheter
itself may also be visualized using the x-ray or fluoroscopy so the
physicians can view the catheter and the patient's vasculature at the
same time. As the physician moves the medical device (e.g. catheter)
through the body of the patient he (or she) uses the x-ray or
fluoroscopic image as presented on a display to help him guide the
interventional device. The human vascular system contains many different
paths, branches or courses to deliver blood to the body and the physician
may only be interested in routing his interventional device in a certain
way to get from the body insertion point to the point of interest.
Therefore, it is critical for a successful procedure for the physician to
see the vasculature, choose and document his path, or course, he wishes
to take on the vasculature roadmap. Whether the physician uses a snapshot
such as x-ray image to help him guide the catheter through the body or a
fluoroscopic moving image to guide the catheter through the body the
physician requires the image to help him guide the device. Briefly,
fluoroscopy is commonly used and is an imaging technique to obtain moving
real time images of a patient's internal structure. Both X-ray and
fluoroscopy involves use of a form of ionizing radiation. Both carry
potential health risks to the patient. The longer the patient is exposed
to the radiation the more severe the potential health risk is to the
patient, therefore it is advantageous to the patient to absorb as little
radiation as possible. Often as the physician uses these interventional
devices, the physician views images obtained via x-ray or fluoroscopy as
it is being displayed on a display monitor during which or after the
catheter procedure. The physician will use a static or real-time
fluoroscopic image to aid in medical procedure, in most cases helping
guide the interventional device to the desired location within the body.
In many cases the physician would like the radiograph dye to be
visualized on the fluoroscope for a period of time longer than it is.

[0003]During the medical device interventional procedure, the physician
using his medical training (or medical device operator) will determine
the best route to direct his interventional device through the patient's
vasculature to treat or diagnose a patient. The physician with treatment
in mind will determine the location of interest, such as, but not limited
to routing a catheter to the location of the blood vessel blockage in
order to treat the blockage. In most cases of a catheter based procedure,
the physician would acquire an x-ray image or angiogram to determine
patient anatomy and in many cases use a fluoroscopic image to feed the
interventional device through the patient to the point of interest within
the patient. Commonly, the patient's anatomy is visibly displayed through
illumination techniques such as x-ray, fluoroscopic, and many different
digital image enhancement techniques including, but not limited to
digital subtraction angiography. Many of the imaging techniques use a
radiopaque injected dye and radiation techniques so the physician can see
the dye as it runs through the human body specifically as it is shown by
x-ray and fluoroscopy medical techniques. The physician will use this
image to determine the best location for routing of the interventional
device to treat the patient. However, radiopaque dye only contrasts or
enhances the blood vessels for a finite period of time. In most cases,
the physician, as he (or she) routes the interventional device views
images on a display monitor of the patient's anatomy and location of the
device as it is passed through the patient. As the physician reviews the
display or angiographic study, the physician may draw, sketch or trace
directly on the display monitor to help him with the procedure or to help
him describe or direct others in the procedure. In other words, while he
views the complex vasculature of the patient with or without the catheter
in place, he traces on the display screen over the medical image to help
him guide and document the procedure. After the dye is gone the physician
cannot see the vasculature and without more dye or a form of road mapping
it is not possible to view the arterial vasculature system of the
patient, so the physician makes these traces and annotations to help
guide him. Presently the physician documents the location of critical
aspects of this procedure by making some of these annotations directly on
the display monitor, conceivably using a grease pencil or marking pen.
Interventional and catheter based procedures performed with x-ray or
fluoroscopy to generate angiographic images by means of ionizing
radiation display the radiographic dye or enhanced vessel for only
several seconds at a time. Therefore, creating a roadmap would enable the
physician to route the device efficiently and safely and to not over
expose the patient or physician operator to harmful radiation by use of
the radioactive equipment for extended periods of time. Specifically, for
example, the physician routing a catheter through the labyrinth of
patients vascular structure will choose the best passage (to get from the
percutaneous location on the body to the desired location within the
vasculature structure) and because the structure is only visible on the
monitor for a finite time, the physician will sketch or trace on the
display monitor as the procedure is performed. This way the physician can
trace his route, notes and document his path to view his route or road
map even after the dye contrast wears off.

[0004]Many physicians will trace a vascular map on the display screen or a
transparent film taped on or mounted over the display screen allowing the
physician to view the vascular placement of the catheter in real-time as
the procedure progresses. The physician will trace, mark, draw a road
map, sketch a placement and perhaps annotate on the transparent film or
screen or monitor as it resides over the display. However because the
opacified blood image is only viewable for seconds the physician may take
and view multiple images before he traces on the overlay or monitor, he
perhaps will choose an image (at that point in time a non enhanced fluoro
image, non subtracted fluoro image) and trace on the overlay or monitor.
The overlay tracing may be used to track the catheter location and
movements relative to the vascular map. Also, the physician traces the
map on the display in the event the patient moves. In other words, if the
catheter location is being tracked on the screen without a trace and the
patient moves, the physician may lose track of his reference point and
may find it necessary to repeat the process resulting in unwanted higher
doses of radiation. Tracing or drawing overlay method presently used by
many physicians comes with many disadvantages, some of which include no
digital permanent record of physicians tracings and instruction,
different displays have different image quality and different displays
have different parallax effect resulting in misinformation as originally
intended.

[0005]It would be desirable to have a simple cost-effective efficient
apparatus and process for the physician to trace, record and add
annotations digitally viewing and documenting the location of the
catheter or other device over the viewed X-ray and/or fluoroscopic image.
The inventor has identified the need and usefulness for such an invention
described herein.

[0006]The traditional way of capturing an image on a medical imaging
machine commonly called a modality, generally consisted of an operator or
technician first conducting a scan. Then using the modality to save the
image, in still or motion video format, into the modality memory or into
a main image storage database. Soon afterward perhaps downloading the
image into a hospital database such as a PACS system, Picture Archiving
and Communications System (or PACS), for storage and later retrieval. The
doctor would then access the PACS system to retrieve the image, the
doctor at that time would call up the image, view and review the image
and conceivably develop a diagnosis based on the information from the
image. This system imagery can accomplish all these tasks in real time.
The illustrated embodiment is comprised of two software application
programs, one called Tele Medicine Imagine Management System (TIMS), the
other called TIMS Fluoro-TRACE®. TIMS is a server type program on a
single computer that is acquiring the medical video signal and
transmitting video and voice signals to a client program. The TIMS
Fluoro-TRACE® system (i.e. this invention described herein) allows for
the physician to input highlighted graphic electronic traces over the
original medical image.

[0007]In one embodiment, TIMS provides the real-time video and audio
communication as well as a method of recording and transmitting images in
DICOM format. DICOM, Digital Imaging and Communications in Medicine, is a
medical imaging standard common in the medical industry. The embodiment
can serve as the connection point between any medical imaging system and
a hospital PACS, patient archival and communications system. One
capability of the TIMS program is to connect older non-DICOM equipment to
a hospital network, allowing imaging studies to be stored in PACS. It can
also be used to connect DICOM compatible equipment, if it desired, to use
some features contained in TIMS that are not available on the imaging
system such as the TIMS Consultant feature, and the TIMS
Fluoro-TRACE®. The TIMS Fluoro-TRACE®, or this invention described
herein as a trace overlay can be stored with the DICOM data and viewable
in PACS.

[0008]In yet another embodiment illustration of this invention, the
physician imputed drawing or tracing can be contained within a direct
digital medical acquisition instrument. In many cases medical-imaging
instruments will contain their own computer system. The direct digital
acquisition system can acquire and store its own digital images. In this
system there is no Tele-Medicine Management System (no external computer,
no external added data management software, no analog to digital
converter) or no need to convert any analog signal to a digital one. The
direct digital medical acquisition system may contain all the necessary
equipment to operate as a computer so will include its own CPU, storage
device, RAM, connections, operating system software, application software
and the like. Therefore, the physician merely uses the direct digital
medical acquisition instrument having this invention loaded therein,
software application to display and record medical images, an input
device allowing the operator to create a line segment drawing over the
displayed image and saving the image with line segment drawing. In
addition to the location of the catheter for an angiogram, there are many
other medical procedures where an interventional device is inserted into
a patient, such as but not limited to endoscopy.

[0009]In most, if not all such procedures, locating, positioning and
recording the interventional device with a patient is extremely
important.

[0010]In the past many other inventors have seen the need to solve the
problem of tracking and documenting the position of the invention devices
as it is in the body and have solved this problem in other ways. Prior
art U.S. Pat. No. 6,515,657 discloses a volumetric ultrasonic imaging
system that superimposes section views created from volumetric ultrasonic
image data and location data for intervention device, such as a catheter.
The position of the intervention device may be shown, in one or more
views relative to organ and tissues with a body as the intervention
device is moved. The intervention device is positional dated is updated
continuously and is superimposed on tissue image data that may be updated
less frequently. Generally most prior art addressing the problem of
locating and tracking an intervention device within the human body has
been found to be inefficient, costly, cumbersome and not necessarily
desired by most physicians. Many different prior arts disclose many
different apparatuses and methods of tracking such devices and many
different ways to enhance medical images to aid the physicians in their
tasks. To date apparatus and methods of tracking and documenting such a
procedure focus on having transmitting and receiving equipment to locate
catheter tracking such as prior art U.S. Pat. No. 6,403,577 and U.S. Pat.
No. 6,226,543. Others use image techniques to enhance digital image
quality such as U.S. Pat. No. 7,233,689.

[0011]Prior art also discloses many different inventions for apparatus and
method of electronic sketching, electronic sketchpad and electronic free
hand sketching. These arts teach many different ways to use electronic
means or computers to sketch, draw or draft line segments on a computer
display using an input device. Typically the input device can be a
stylus, a mouse, touch pad or touch screen. Other input devices include
but are not limited to keyboards, touch screens, touch pad, trackballs,
light pens, graphics tablet and joysticks. All input devices mentioned
herein are operated by the human hand or human finger, such as movement
of a computer mouse or by touching a screen or touch pad. It is common in
the art sketching segments or line segments sometimes know as computer
aided drafting or computer aided design. Among the many prior arts
include, U.S. Pat. No. 4,764,763 An Electronic Sketching Device, and U.S.
Pat. No. 6,233,351 Method and Apparatus for Processing a Freehand Sketch.
However no prior art technology allows a physician to trace
electronically line segments and notations over newly acquired or
existing medical imagery.

[0012]The inventor has developed a novel and simple apparatus and method
to allow a physician to trace, annotate and store images while using
medical intervention technologies.

SUMMARY

[0013]The invention relates generally to a medical apparatus and method of
using the same for generating a virtual road map guide of a patient's
anatomy for use by a medical professional while conducting a procedure on
the patient. The apparatus including a medical image acquisition system
adapted for receiving and transmitting medical images, constructed from,
a computer having communications capability adapted for acquisition and
transmission of a plurality of medical imaging video signals wherein the
video signals are acquired from a transmitting medical device in the
medical device's native resolutions, transmitting the signals at their
native resolutions to a receiving device receiving the medical imaging
video signals in analog or digital source and if required compressing
and/or scaling the signal, converting the signal to digital form for
transmission, and transmitting the digital signals to a display device.
The medical image acquisition system is capable of acquiring signals from
a plurality of medical imaging systems including but not limited to,
ultrasound, Computer Tomography (CT) scan, fluoroscopy, endoscopy,
magnetic resonance imaging, nuclear medicine, echocardiogram ultrasound
and microscopy. The medical receiving device receiving the video image
signal in a plurality of video sources including but not limited to,
S-video, composite color and monochrome, component red blue green video
(RGB, three additive primary colors), digital visual interface (DVI,
digital standard interface) and high definition multimedia interface
(HDMI, compact audio video interface uncompressed digital data), serial
digital interface (SDI, serial digital interface) and DICOM video. The
apparatus including a storage device adapted for archiving the video
signal in a predetermined digital format including Digital Imaging and
Communications for Medicine (or DICOM), Audio/Video Interleaved.
Transmitting data includes transmitting the data in secure encryption
protocols. Transmitting video signal resolution at the same resolution as
the received signal. In one illustration, a remote location communicates
with the networked computer, for the purpose of collaborating and
conferencing.

[0014]An apparatus and method for using a medical image acquisition system
for receiving, transmitting and road mapping medical image data,
following the steps of acquiring image data from an image producing
medical device, receiving medical video signals into a computer
converter, compressing the video signals, converting the video signals to
digital images, the medical image acquisition system connecting
transmitting streaming image data instantaneously, the operator using an
input device sketching lines, draws arcs, line segments, shapes and
annotations over the medical video signals the medical acquisition system
storing the image data.

[0015]An example or illustration of use may be, as the physician is
viewing the image on the display, specially viewing a fluoroscopic image
of the patient's vascular image possibly having a catheter in the
patient, the physician can use the input device to trace or draw line
segments to highlight the vascular path he wishes to take or merely to
document or record the present location of the catheter within the
patient. In addition the physician may also use the input device to
create lines, line segment or annotations, to callout, highlight or map
specific locations or points of interest such as but not limited to where
he wishes to place a stent within the patient's vasculature. These
drawing features can also be used as a teaching tool, directing
physicians as to what the plan for the procedure is. It can also be used
to document the planned procedure. The physician can also use these
drawing features to draw a land mark such as on the ribs or vertebral
body in the event the intervention device (image intensifier) must be
moved during the procedure then repositioned later to be in line with the
original roadmap.

[0016]The hardware input device sends information into the computers
central processing unit (CPU). For example when an operator moves the
mouse on a flat surface in an X-Y motion (left, right, up, down) a line
segment will appear on the computer display (light pixels on the display
illuminate to depict a viewable segment on the display). The line
segments will appear in a changeable contrasting color to the original
viewed medical image. The physician can also annotate or sign his name
using the input device. Basic touch screen mechanics can also mimic
computer mouse depress (click) and drag features. Characteristically the
operator of the computer input sometimes referred to as a mouse can
depress or click and hold the button while moving the mouse can create
the line segment. Capturing the freehand line segment positions and
storing the overlay typically as a one bit bitmap computer file format.
The DICOM standard provides tags for storing this data The highlighted
image of line segments may look like a tree and branch like structure as
the human vascular structure may look like or sometime know as
highlighting a road map through the vascular. The physician or operator
can also erase or clear any, line segment, line, curve, drawing, trace,
entire screen or annotation. Typically the physician can draw by
depressing or clicking the input device such as a computer mouse button
that toggles drawing or erasing. The operator can also use the input
device to clear the entire entry.

[0017]The principle preferred embodiment and modes of operation of the
present invention have been described in the forgoing specification. The
invention which is intended to be protected herein, however, is not to be
construed as limited to the particular embodiments disclosed, since these
embodiments are to be regarded as illustrative rather than restrictive.
Variations and changes may be made by others without departing from the
spirit of this invention. Accordingly, it is expressly intended that all
such variation and changes which fall within the spirit and scope of the
claims be embraced thereby.

BRIEF DESCRIPTION OF DRAWINGS

[0018]Other objects, features, and advantages will occur to those skilled
in the art from the following description of an embodiment and the
accompanying drawings, in which:

[0019]FIG. 1, shows a screen shot of an image of human vasculature with
catheter

[0020]FIG. 2, shows a screen shot of an image of human vasculature with
catheter having highlight imagery

[0022]FIG. 4, shows a screen shot of embedded highlighted image with other
images

DETAILED DESCRIPTION

[0023]An apparatus medical image acquisition system for displaying and
recording medical images 1 and producing a virtual road map 16 of a
patients anatomy 2 for use by a physician during an intra-body medical
procedure. The medical image acquisition system having an intervention
device 3 acquiring system signals from a plurality of medical imaging
systems including but not limited to; ultrasound 4, Computer Tomography
(CT) scan 5, fluoroscopy 6, endoscopy 7, magnetic resonance imaging 8,
nuclear medicine, echocardiogram ultrasound 9, angiograph 10 and
microscopy. The medical image acquisition system computer 1 adapted for
acquisition of a plurality of medical imaging video signals wherein
signals are acquired from a transmitting medical device, 4,5,6,7,8,9,10
in the medical device's native resolution having a central processing
unit 11, a display 12, at least one input device 13 such as a computer
mouse, stylus pen, track ball, tablet or touch screen display, a storage
device 14 that is typically a computer having a central processing unit
and file storage media such as a hard drive, an output device such as a
display monitor or printer 15 wherein the medical image is displayed on
the display 12 (or monitor), bus bar connections, operating software and
application software. The image generating device 1 for generating for a
virtual road map 16, wherein the virtual road map 16 comprises a two
dimensional image illustrations representing anatomy structure as imputed
by and operator 16. The apparatus for displaying and recording medical
images 1 and producing a virtual road map 16 of a patient's anatomy for
use by a physician during an intra-body medical procedure where the
illustration represents operators input annotations 17.

[0024]The apparatus for displaying and recording medical images 1 and
producing a virtual road map of a patient's anatomy 16 for use by a
physician during an intra-body medical procedure where in the
illustration represents vascular structure 2. In addition the medical
image also can show the location of the intervention device such as a
catheter 18.

[0025]A method of displaying and recording a medical image 1 during an
intra-body medical procedure providing a medical image to a medical image
acquisition acquiring a plurality of medical imaging video signals
wherein signals are acquired from a transmitting medical device
4,5,6,7,8,9,10 in the medical device's native resolution having a central
processing unit 11, 14, a display 12, at least one input device 13, a
storage device 14, an output device wherein the medical image is
displayed on the display 12; displaying the medical image on the display,
viewing the medical image, the operator positioning the input device 13
wherein a line segment 16 appearing on the display 12, the operator,
tracing segments 16 using the input device 13, the segments appearing on
the display 12 resembling a road map 16, creating curve segments
coincident to the medical image 2.